Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach

Colorectal Cancer Clinical Trial

— CRCSO  

Official title:

Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594150
• Other study ID #: 823388
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.

Description:

This is a single center 4-arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives. Potentially eligible subjects will be identified via a data abstraction by Penn Data Store. We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the data abstraction using PennChart to confirm eligibility until 1,080 patients are identified. We will then randomize these 1,080 patients to one of four arms during the intervention phase.

• Arm 1: mailed FIT kit (usual care)

• Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive)

• Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two months (conditional fixed incentive)

• Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is returned within two months (conditional lottery incentive) All 1,080 subjects will receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks after the kit was mailed to the subject. Subjects whose FIT results are not recorded in PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to the subject. Subjects will receive follow-up regardless of the arm to which they are randomized.

A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this sub-sample. This phone call will occur after the intervention and follow-up phases are completed. Analysis will occur after the sub-sample questionnaire phase is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 897
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Between 50 to 75 years old

• Has had at least two visits at Penn Family Care Within the past two years - Due for screening

• Asymptomatic for colorectal cancer (CRC)

• Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area

• Have a primary care provider in Penn Family Care

Exclusion Criteria:

• Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)

• Has a history of CRC

• Has a history of other GI cancer

• Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)

• Has history of colitis other than Crohn's disease or ulcerative colitis

• Has had a colectomy

• Has a relative that has been diagnosed with CRC

• Has been diagnosed with Lynch Syndrome (i.e. HNPCC)

• Has been diagnosed with Familial Adenomatous Polyposis (FAP)

• Has anemia (iron-deficient or general/unspecified)

• Has history of lower GI bleeding

• Has metastatic (Stage IV) blood or solid tumor cancer

• Has end stage renal disease

• Has had congestive heart failure

• Has dementia

• Has cirrhosis or end stage liver disease

• Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Financial Incentive
Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in return rate of completed FIT	An increase in return rate of completed FIT between intervention arms when compared to the control arm	2 months